Brief: Chiesi Global Rare Diseases Seeks Ema Chmp Re-Exam Of Negative View On Elfabrio 2 Mg/Kg Q4w Dosing

Protalix BioTherapeutics

03/11/2025 23:06

Nov 3 (Reuters) - CHIESI GLOBAL RARE DISEASES-

CHIESI GLOBAL RARE DISEASES - REQUESTS RE-EXAMINATION OF NEGATIVE OPINION ISSUED BY EMA'S CHMP ON PROPOSED DOSING REGIMEN OF 2 MG/KG EVERY 4 WEEKS FOR ELFABRIO

CHIESI GLOBAL RARE DISEASES AND PROTALIX BIOTHERAPEUTICS SEEK RE-EXAMINATION FROM THE EMA FOR THE NEGATIVE OPINION FOR ELFABRIO (PEGUNIGALSIDASE ALFA) ALTERNATIVE DOSING REGIMEN OF EVERY FOUR WEEKS IN THE EU

CHIESI GLOBAL RARE DISEASES - EXISTING MARKETING AUTHORIZATION FOR ELFABRIO REMAINS IN EFFECT

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